Recall Z-1119-2022 ยท EFQ Gauze/Sponge, Internal
Steris Corporation
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100
| Date | Mar 22, 2022 |
| Status | Terminated |
| Reason | Product not approved for release for US distribution |
| Root cause | Other |
| Action | Crosstex notified accounts by Urgent Medical Device Recall letter dated 3/22/22 via email. Letter states reason for recall, health risk and action to take: 1. Please immediately inspect on-hand inventory for Ultra Pure Non-Woven Sponges, lot #202108 (part numbers ENC100 and ENC4100). 2. Please reply via email or complete the Recall Response Form included with this Notification Letter and return to cvalderrama@hu-friedy.com. Crosstex will provide instructions for returning the affected product to us. 3. Identify and notify all Customers who you have further distributed the affected product. Imp |
| Quantity | 152 cases |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984187 | CROSSTEX NON-WOVEN SPONGES Crosstex Intl., Feb 18, 1999 |